CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,290 enrolled
Drug / intervention
IMARA (intervention group) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04758390
NCT04758390N/ACompleted

Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women

University of Illinois at Chicago·interventional·Posted Feb 17, 2021·Updated Jan 20, 2025

In Brief

A clinical study evaluating IMARA (intervention group) and Health promotion control group for Sexually Transmitted Infections and HIV Infections. Completed, enrolled 1,290 participants across 1 site.

Detailed Summary

To achieve an AIDS-free generation, there is a critical need for programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa. Informed, Motivated, Aware, and Responsible Adolescents and Adults (IMARA) is an evidence-based HIV-prevention intervention for adolescent girls and young women (AGYW) and their female caregivers, which has been adapted for a South African audience. The study will test whether AGYW receiving IMARA will have fewer sexually-transmitted infections (STI) and greater acceptance of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at 6-month follow-up compared to AGYW assigned to the health-promotion control intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Africa

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 17, 2021
Enrollment StartOct 2, 2021
Primary CompletionApr 7, 2024
Study CompletionOct 4, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.4 years ago

Interventions

IMARA (intervention group)behavioral

The IMARA intervention aligns with an ecological framework, emphasizing the intersection of individual, social, and structural determinants of women's sexual health and behavior. Separate FC and AGYW groups run simultaneously and cover parallel content, while joint activities enhance FC credibility as a resource for HIV/STI prevention and facilitate practice of communication skills. Interventionists use interactive and experiential activities. IMARA's goals and motto emphasize strong FC-AGYW relationships, sisterhood, community empowerment, and motivation for HIV prevention, and build group cohesion. FC and AGYW sign a pact to confirm commitment to the program. At the end of Workshop Day 1, participants receive homework to complete during the week. Woven throughout IMARA is the impact of mental health issues, alcohol and drug use, and violence on HIV-risk.

Health promotion control groupbehavioral

The health promotion control intervention is a family-based intervention previously delivered to families in SA and translated into isiXhosa. The intervention promotes healthy living by encouraging good nutrition, exercise, and violence reduction. It will be delivered in the same format as IMARA and will be identical in length and intensity.